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Bigfoot’s fundraising momentum continued today, as it announced an investment from the T1D Exchange’s new Automated Insulin Delivery (AID) Investment Initiative. The terms were not disclosed, but we assume it is in the multi-million dollar range. This is the Exchange’s first investment following the Initiative’s announcement last fall, and clearly a big vote of confidence in Bigfoot’s rapid progress and path to market. The press release notes that Bigfoot will begin its pivotal trial “later this year” at sites across the US, slightly wider timing than the previous “mid-2017” plan. Bigfoot CEO Jeffrey Brewer told us that the pivotal timing is contingent on signing a commercial agreement with Dexcom, which does not currently exist; in the meantime, Bigfoot is aggressively exploring other options. At the JDRF Mission Summit two weeks ago, Mr. Brewer shared expectations for an FDA submission in 2018, enabling a potential launch in early 2019. He also confirmed plans to pursue a Series B round of ~$30-$5o million in 2Q17, complementing Bigfoot’s two other recent fundraising wins: the first investment out of JDRF’s new T1D Fund (three weeks ago) and a $35 million Series A round (in October). The Bigfoot press release is well worth a read, as is a look at the company’s updated website – there is definitely a lot of design and thought going into this product and the very authentic company vision (especially these great “What if” questions). In July, Bigfoot started enrolling pediatric and adult patients in its first clinical trial of smartloop, which has since completed.

From the press release: “Bigfoot’s approach includes delivering the first Internet-of-Things medical device, a cloud-connected system bundled as a monthly subscription service, to a broad population historically challenged by the high upfront costs of traditional insulin delivery hardware. Designed from the ground up to be user friendly and with thoughtful approaches to alarms and escalation, Bigfoot’s smartloop will leverage the power of its smartphone-connected service and best-in-class components to deliver on outcomes valued by patients, providers, and payers.”

The first line of the press release actually calls Bigfoot “a highly anticipated machine learning company.” Mr. Brewer told us that Bigfoot's secret sauce consists of the layers of machine learning algorithms that work to take glucose data and titrate insulin, either in real time as a closed-loop infusion system or episodically through dosing recommendations for injections. The company’s machine learning algorithms are also designed to eliminate the traditional setup parameters of insulin pumps, and make CGM alarms less onerous, more actionable, and with fewer false alarms.